FDA releases final foreign supplier rule

The U.S. Food and Drug Administration (FDA) has released its final rule for Foreign Supplier Verification Programs (FSVP) for Food for Humans and Animals. This rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA). Most importers will be required to comply with FDA’s FSVP rule in May 2017 (18 months after publication).
FDA defines an FSVP as a program that verifies “that (importers’) foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.” The FSVP rule covers importers of food and beverages, which FDA defines as “the U.S. owner or consignee of a food offered for import into the United States.” If there is no U.S. owner or consignee, the exporter’s U.S. agent is the importer.
Importers must create an FSVP for each food imported from each foreign supplier. If they import the same food from two different suppliers, that will require two FSVPs. One element of an FSVP is a hazard analysis. Importers must determine potential biological, chemical, and physical hazards posed by each food they import.
Importers must also evaluate the performance of each of their foreign suppliers and use that evaluation to approve suppliers. This includes evaluating each supplier’s history of compliance with FDA food safety regulations, “including whether the foreign supplier is the subject of an FDA warning letter or import alert.” Importers should only import from approved foreign suppliers.
For approved foreign suppliers, importers must determine appropriate supplier verification activities, conduct those activities, and conduct corrective actions. Examples of verification activities may include annual on-site audits of a supplier’s facility, sampling and testing, and review of a supplier’s food safety records. Importers should choose verification activities that appropriately fit the risks of each supplier.
Importers may designate a third party to conduct a hazard analysis, a supplier risk evaluation, or to perform verification activities on their behalf. Registrar Corp’s food safety specialists can develop or review a food safety plan that identifies potential hazards associated with a food or supplier and a plan to control those hazards. Registrar Corp also offers an FDA Compliance Monitor, which food facilities may use to monitor their foreign suppliers for FDA inspections, warning letters, import alerts and import refusals. The monitor is updated consistently, allowing importers to take prompt corrective action.

FDA focuses on FSMA Phase 2 implementation

The Food and Drug Administration (FDA) focused on implementation of Phase 2 of the Food Safety Modernization Act (FSMA) at its public meeting in Chicago on October 20.
According to Roberta Wagner, associate director for FSMA operations, Center for Food Safety and Applied Nutrition at the FDA, FSMA is being implemented in three phases:

• Phase 1: Setting standards by developing regulations and policy.
• Phase 2: Designing strategies to promote and oversee industry compliance by identifying performance metrics to measure success.
• Phase 3: Transitioning strategies and performance metrics from design to operation and evaluating their success.

To implement Phase 2, which is the next step in the process, FSMA workgroups were established by the FDA’s food and veterinary medicine executive council. Those workgroups are charged with developing the framework and multi-year implementation plan for ensuring compliance.
“We’ve set ourselves up so we are not operating in silos within the agency,” Wagner said.
Guiding Phase 2 FSMA implementation is a Program Alignment Initiative that relies on several factors to result in successful FSMA implementation:

• Vertically integrated, commodity-based programs
• Specialization of inspection and compliance staff and regulatory labs
• Clear, current and consistently applied policy
• Streamlined decision-making
• Risk-based allocation of program resources
• Agreed-upon performance and public health metrics

Key implementation principles

Joann Givens, food and feed program director for the FDA Office of Regulatory Affairs, explained that Phase 2 implementation relied on several key principles. Those are:

• Industry education, outreach and technical assistance: This can be achieved by facilitating industry compliance with prevention-oriented standards through guidance documents, tools and resources for education, alliances with stakeholders, and technical assistance networks.
• Regulator training: Stringent training will promote uniform, quality inspections, which will result in consistent decision-making by regulators.
• Inspections: Systems-based inspections, as opposed to observation-focused ones, will be interactive and cooperative.  
• Compliance and enforcement: The development and implementation of explicit inspection and enforcement strategies will facilitate consistent decision-making by regulators. The FDA also will encourage the industry to comply with regulations and make corrections on its own. The agency says it realizes that not all observations are equal relative to risk and the potential for public health impact and that it is aiming for a dynamic regulatory strategy.
• Accountability and stakeholder engagement: The FDA is looking to develop meaningful public health and performance metrics to measure the success of FSMA implementation. It says it recognizes the role of the marketplace in influencing and expanding industry compliance with FSMA rules and therefore plans to work closely with industry, government agencies, academia, other key stakeholders and partners.

FDA says most animal drug companies on board with Guidance #213

The U.S. Food and Drug Administration (FDA) said that, since it announced final Guidance for Industry #213 in December 2013, all but one animal drug company have committed in writing to seek withdrawal of approvals for any production uses of affected drug applications and change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription.
On December 11, 2013, the FDA announced the implementation of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes. FDA asked affected sponsors to notify the agency in writing within three months of their intent to engage with FDA as defined in Guidance #213.

FDA makes FSMA deadline extension official

The U.S. Food and Drug Administration (FDA) on January 31 officially extended the comment period deadline on the proposed animal food rule under the Food Safety Modernization Act (FSMA).
Animal feed and pet food industry trade associations previously had been made aware of FDA's intent to do so, but welcomed the announcement of the extension in the Federal Register.
The announcement comes after the American Feed Industry Association (AFIA), National Grain and Feed Association (NGFA), National Renderers Association (NRA) and the Pet Food Institute (PFI) submitted a joint request for extension to FDA on November 22, 2013. The extension moves the comment period deadline from February 26 to March 31, 2014.
"Although the submission deadline could only be pushed back a few weeks due to a court-mandated timeline, the extension gives our organizations valuable time to continue to review the rule and develop comprehensive and substantive comments for submission to the agency," said the AFIA, NGFA, NRA and PFI in a joint statement.
The associations' decision to request an extension was based on the significant scope and magnitude of the proposed rule for animal feed and pet food.  With the extension, the comment period on the animal food rule will be open only five months.  In contrast, the human food proposed rule, which animal food rule mirrored, was open for nine months.
In addition to the proposed animal food rule, officially titled "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals," industry groups are reviewing separate rules on foreign supplier verification, third-party auditors and intentional adulteration.  In addition, the FDA posted on its website its proposed rules implementing FSMA's sanitary food transportation provisions, with official publication in the Federal Register due next week.
The agency said it is unlikely to grant extensions for other FSMA proposed rules due to the strict timeline the agency is required to follow under court order.

FDA withdraws 98 of 101 arsenic-based animal drug approvals

In a letter responding to a petition brought by nine major health and environmental organizations, on September 30, the U.S. Food and Drug Administration (FDA) announced that it will withdraw 98 of 101 approvals given to arsenic-based animal drugs.
This action will remove three of the four arsenic-containing drugs used in the production of poultry and hogs. The FDA's decision comes almost four years after a petition was filed by the Institute for Agriculture Trade and Policy and the Center for Food Safety asking that the agency withdraw its approval of the drugs.
"This move by the FDA is an important validation to the work being done in the health care sector to bring attention to the public and environmental health effects of arsenic-containing food additives in poultry production," said Emma Sirois, co-chair of Health Care Without Harm's Healthy Food in Health Care Program. "As large purchasers of food, hospitals in HCWH's network have been asking their suppliers to identify poultry grown without these drugs - sending a strong signal to the market to change this production practice in support of public health."
Arsenic-based drugs are used in animal agriculture because they speed weight gain and provide enhanced color to poultry meat. A 2006 IATP study showed that 70 percent of U.S.-produced chickens are fed these drugs. In a letter explaining its decision, the FDA cited a recent study, including one by petitioner Center for a Livable Future, that challenged previous assumptions of the safety of these drugs in humans consuming meat of animals raised using them. In particular, concern arose over the ability of organic arsenic to transform into inorganic arsenic, a known carcinogen, in the environment or animal tissue.
The FDA has not yet made a ruling on nitarsone, an arsenic-containing compound that is still being used in poultry products. The petitioners will conduct research on how to proceed. Their ultimate goal is for the FDA to withdraw approvals for all arsenic-based animal drugs.

FDA denies citizen petition on arsenic-based animal drugs

The U.S. Food and Drug Administration (FDA) on October 1 denied a petition from the Center for Food Safety and the Institute for Agriculture and Trade Policy that asked the agency to take steps to revoke the approvals of four arsenic-based animal drugs. The petitioners' requests with respect to three of the four drugs at issue became moot after the sponsors of those drugs requested that FDA withdraw the approvals for those products.
In response to the announcement, Ashley Peterson, Ph.D., National Chicken Council vice president of scientific and regulatory affairs, released the following statement:
"The only arsenical used as a feed additive in broiler production in the last 10 years, Roxarsone, was suspended in 2011 and the product is no longer manufactured or used. No other feed additives containing arsenic are currently used in broiler meat production in the United States."
With respect to the only remaining approved arsenic-based animal drug, FDA said it denied the petitioner's request because the agency is in the process of completing several scientific studies and reviewing and evaluating information to help the agency more-fully evaluate any potential concerns related to the safety of arsenic-based animal drugs. This drug, nitarsone, is not used in U.S. broiler production

FDA issues guidance on color additives in animal food

The U.S. Food and Drug Administration has issued a document intended to help small businesses comply with regulations on declaring color additives in food for animals.
The document, entitled Small Entity Compliance Guide - Declaring Color Additives in Animal Foods, provides background and questions and answers on the 2011 regulation requiring that all color additives subject to the FDA's certification process be listed on the product label for animal feed or pet food. Color additives exempt from certification generally include those derived from plants or minerals.
All animal feed and pet food manufacturers must comply with the rule by November 18.

FDA issues guidance for animal food additive petitions

The U.S. Food and Drug Administration has announced the availability of a draft document describing the type of information it recommends that companies provide when they submit a food additive petition for substances intended for use in animal food.
Under the Federal Food, Drug and Cosmetic Act, the FDA must approve food additives before they can be used in animal food.
The draft Guidance for Industry #221, titled "Recommendations for Preparation and Submission of Animal Food Additive Petitions," recommends that petitioners submit to FDA:

• Information to identify and characterize the food additive
• Information about the manufacturing methods and controls
• Data to show the food additive will have its intended effect and the amount of the food additive needed to achieve the intended effect
• The proposed labeling
• A description of the method or methods used to determine the strength, purity and quality of the food additive
• A safety evaluation of the food additive (this includes evaluating the safety to people who eat edible products of animals fed the food additive and the safety to the target animal species)
• Proposed tolerances for the food additive (this represents the maximum concentration of the additive allowed in edible tissues, for example, in meat, milk and eggs)
• Proposed food additive regulation describing the conditions under which the additive can be safely used in animal food
• Information to allow the FDA to assess the environmental impact from the manufacture, use and disposal of the food additive
The draft guidance is open for public comment for 60 days, starting on September 11. Although you can comment on any guidance at any time, to ensure that the FDA considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 12, 2013.

FDA releases proposed rule on preventative controls for human food

The U.S. Food and Drug Administration has released the proposed rule on preventive controls that applies to many domestic and foreign firms that manufacture, process, pack or hold human food. The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. The FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly.

Key points of the Proposed Rule
The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:

• Hazard analysis
• Risk-based preventive control
• Monitoring procedures
• Corrective actions, verification and record keeping
The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points systems.

Implementation of the rule
FDA is proposing that the requirements be effective one year after a final rule is published in the Federal Register. The agency is proposing to allow two years for small businesses and three years for very small businesses to comply with the rule.
Comments on the proposed rule are due 120 days after the rule is published in the Federal Register. FDA will hold public meetings to explain the proposal and to provide additional opportunity for input.
FDA also released for public comment another proposed rule in response to the 2011 Food Safety Modernization Act. In addition to the preventative controls for human food, FDA released the proposed rule on standards for the safe production and harvesting of produce. FDA said that its proposed rule on importer foreign supplier verification will be issued soon.

FDA allows ionizing radiation of meat, poultry products

The Food and Drug Administration has amended the food additive regulations to provide for the safe use of ionizing radiation on meat and poultry products, according to final rules released in the Federal Register.
The first final rule provides for the use of a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation to treat unrefrigerated and refrigerated uncooked meat, meat byproducts and certain meat food products to reduce levels of foodborne pathogens and extend shelf life. The second final rule amends the food additive regulations to increase the maximum dose of ionizing radiation permitted in the treatment of poultry products, to include specific language intended to clarify the poultry products covered by the regulations, and to remove the limitation that any packaging used during irradiation of poultry shall not exclude oxygen.
Both rules go into effect on November 30.

FDA finalizes plan for limiting antibiotics in animal feed

The Food and Drug Administration has finalized a plan for asking drug companies to voluntarily limit the use of certain antibiotics in animal feed, in the wake of a U.S. federal judge's decision that their overuse is endangering human health by promoting the development of antibiotic-resistant superbugs.
The FDA is asking drugmakers to stop using 200 products for growth promotion and instead use them just to treat and prevent diseases. Companies that opt to do so will be required to revise their product labels to reflect the change, and once the antibiotics are relabeled they will no longer be available to farmers over the counter. “It is critical that we take action to protect public health,” said FDA Commissioner Margaret A. Hamburg, M.D. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available.”
The FDA has issued three documents to help veterinarians, farmers and animals producers use medically important antibiotics judiciously in food-producing animals by targeting their use to only address diseases and health problems:

• A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
• A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.
• A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.
The industry is now turning its attention to the details of how the plan will be put in place, particularly to the role veterinarians will play.

Release of regulations for Food Safety Modernization Act delayed

The Food and Drug Administration’s release of proposed regulations to implement the cornerstone of the Food Safety Modernization Act has been delayed by the White House Office of Management and Budget, which is still in the review stage.
The FDA had hoped to release four separate sets of proposed regulations on January 4, the one-year anniversary of the Food Safety Modernization Act's signing into law. Two of those sets of proposed rules will pertain to the requirement that food and feed facilities analyze hazards, implement appropriate preventive controls and develop written food/feed safety plans — each of which is intended to minimize or prevent the potential for products to be adulterated or misbranded. One of the sets is to address human food, and will consist of a 400-page preamble, 200 pages of economic analysis and the regulations themselves. The second set will be for animal feed, feed ingredient and pet food manufacturers, and consist of a 200-page preamble, 100-page economic analysis and the text of the proposed regulations. The other two sets of proposed regulations pertain to law’s requirements that food and feed facilities implement a foreign supplier verification program; and produce growers and handlers implement hazard analysis, preventive controls and product-tracing systems for such products as fruits, vegetables, spinach and lettuce. The final regulations must take effect by July 3.

USDA, FDA to provide flood-damaged crop assistance

The U.S. Department of Agriculture and the U.S. Food and Drug Administration are working together to provide assistance to farmers whose crops were damaged by severe flooding from Hurricane Irene and Tropical Storm Lee. 
The FDA considers ready-to-eat crops whose edible portion has been in contact with flood waters to be adulterated due to potential exposure to sewage, animal waste, heavy metals, pathogenic microorganisms or other contaminants. Therefore, these crops should not enter the food or animal feed supply. Crops insured by federal crop insurance or by the Noninsured Disaster Assistance Program are covered when floodwaters have rendered them valueless. "We are working closely with the FDA to protect people and livestock from damaged crops, while not penalizing the farmer whose crops are affected," said Michael Scuse, acting under secretary for Farm and Foreign Agricultural Services. "I want to assure insured farmers that they are covered under the federal crop insurance program for crops not harvested due to flood damage."
Disposition of crops in proximity to, or exposed to a lesser degree of flooding, where the edible portion of the crop has not come in contact with flood waters, may need to be evaluated on a case-by-case basis. The USDA encourages all farmers and ranchers to contact their crop insurance companies and local USDA Farm Service Agency Service Centers, as applicable, to report damages to crops or livestock loss. More information about federal crop insurance may be found at http://www.rma.usda.gov/. Additional resources to help farmers and ranchers deal with flooding may be found at www.usda.gov/disaster.

FDA issues interim final rules for Food Safety Modernization Act

The Food and Drug Administration has published two interim final rules in the Federal Register, regarding the FDA's administrative detention authority and advanced notice of rejected imports, connected to the Food Safety Modernization Act.
The first interim final rule relates to the FDA’s administrative detention authority. Currently, the FDA has the authority to detain products deemed to have “credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.” Under the FSMA, the criteria level has been modified to the more general definition “reason to believe that the article of food is adulterated or misbranded.” This change in administrative detention authority widens the FDA’s scope of products acceptable for detention to products that would normally be considered as part of a Class II recall.
The second interim final rule relates to importers giving advanced notice of imports that were refused entry into another country. Presently, importers must give the FDA advanced notice of imports electronically through a Customs and Border Protection or FDA system. This interim final rule implements an FSMA-mandated requirement that this prior notice include the identity of any country to which an article of food has been refused entry.
The requirements in both interim final rules will be effective July 3, 2011. Comments will be accepted on both interim final rules and reviewed by the American Feed Industry Association's FSMA work groups.

US Government Accountability Office report declares need for 'single food safety agency'

The U.S Government Accountability Office has released a report, "Opportunities to Reduce Potential Duplication in Government Programs, Save Tax Dollars, and Enhance Revenue," focusing on identifying federal programs, agencies, offices and initiatives which have duplicate goals or activities in an attempt to reduce government spending. Among the areas focused on was agriculture, and the GAO determined that the current "fragmented food safety system has caused inconsistent oversight, ineffective coordination and inefficient use of resources."
According to the GAO, fifteen federal agencies collectively administer at least 30 food-related laws. Budget obligations for the two primary food safety agencies, the Food and Drug Administration and the U.S. Department of Agriculture's Food Safety and Inspection Service, totaled $1.6 billion in fiscal year 2009.
To address the fragmentation, and the inherent problems of such scattered oversight, the GAO suggested several potential alternative organizational structures:

• a single food safety agency, either housed within an existing agency or established as an independent entity, that assumes responsibility for all aspects of food safety at the federal level;
• a single food safety inspection agency that assumes responsibility for food safety inspection activities, but not other activities, under an existing department, such as the USDA or FDA;
• a data collection and risk analysis center for food safety that consolidates data collected from a variety of sources and analyzes it at the national level to support risk-based decision making; or
• a coordination mechanism that provides centralized, executive leadership for the existing organizational structure, led by a central chair who would be appointed by the president and have control over resources.

Although reducing fragmentation in federal food safety oversight is not expected to result in significant cost savings, said the GAO report, new costs may be avoided by preventing further fragmentation.

FDA applies next-generation sequencing in Salmonella montevideo investigation

The Food and Drug Administration has reported that their scientists have successfully applied a new genome-sequencing assay to determine the source of an outbreak of Salmonella montevideo.
Approximately 300 consumers of processed meat products were affected in 44 states, with the peak of cases in November 2009. Next-generation sequencing on 35 samples of cold cuts identified the common origin of the outbreak to a single food plant and identified the vehicle, a spiced meat rub. The investigation, which was published in the Feb. 23, 2011, edition of the New England Journal of Medicine, demonstrated that the technique was superior to conventional pulse-field gel electrophoresis, which is less specific than NGS technology. The assay was able to eliminate other potential sources of infection which yielded an S. montevideo with an identical PFGE pattern.
The significance of this report is that the FDA is now equipped at a higher level to identify the origin of SE outbreaks with absolute precision. Additional information and the history of the outbreak updated can be assessed on the Centers for Disease Control website.

FDA schedules March hearing on Food Safety Modernization Act implementation

The U.S. Food and Drug Administration will hold a meeting on March 29, allowing companies to provide input on how the agency implements the Food Safety Modernization Act's import safety provisions.
FDA's notice said the agency seeks information on importer verification, the Voluntary Qualified Importer Program, import certifications for food, and third-party accreditation.
The meeting will take place from 9 a.m. to 5 p.m. EDT in Silver Spring, Md., and will be available on that day as a live webcast. FDA also scheduled a public hearing on March 30 and 31 in College Park, Md., to discuss its use of international comparability assessments to enhance the safety of imported foods and animal feed.

FDA warns Ohio Fresh egg producer

According to public records, the Cincinnati District Office of the Food and Drug Administration has issued a warning letter to the management of Ohio Fresh Eggs LLC dated February 25, 2011. The action was taken as a result of failure by the producer to divert eggs to pasteurization following consecutive SE positive egg assays.
The eggs in question were recalled with minimal publicity and with no evidence of adverse effects among consumers. In addition, this producer was cited for failure to initiate egg assays following a positive environmental sample.
It is noted that Ohio Fresh Eggs LLC is ultimately controlled by Jack Austin DeCoster who was involved in the August 2010 SE egg recall from his farms in Iowa, which resulted in extensive losses estimated to be in excess of $100 million to the U.S. shell-egg industry.
The documented deviations from required action in the event of an environmental positive must be regarded in a serious light by both the regulatory authorities and the industry. Any negligence or unscrupulous practice which may compromise safety has the potential to degrade the image of our product. The actions of a minority could easily invalidate progress made by the American Egg Board in promoting consumption. It must be remembered that the American Egg Board is funded through a check-off program to which all producers contribute. The collective responsibility of all stakeholders in egg production is self-evident.

FDA seeks increase in funding

The U.S. Food and Drug Administration has requested a 33% increase in their FY 2011 budget allowance over the previous allocation of $4.3 billion.
In supporting the request, Margaret A. Hamberg MD, Commissioner of the Food and Drug Agency stated, “The breadth of this mandate means that FDA responsibilities continue to grow.” She was referring to the recently enacted but as yet unfunded Food Safety Modernization Act. The critical initiatives that will require an increase in budget include:

• Transforming the Food Safety and Nutrition Initiative: The $324 million requested will be devoted to the Food Safety Modernization Act and to activities which will encourage citizens to make healthier food choices. Prevention of food-borne diseases will be carried out in cooperation with state and local partners.
• Advancing the Medical Counter Measure Initiative: The $70 million will be required to develop medical countermeasures to respond to national security threats. The legal, regulatory and policy framework of the program will be updated.
• Expanding the Protecting Patients Initiative: Funded at $124 million this program will establish approval for “biosimilars” (analogous to generics) similar in clinical action to existing FDA-approved biological products.
• Intensifying the Regulatory Science Facility Initiative: The $49 million requested would be applied to strengthen the regulatory scientific capacity required to support FDA missions.

Given the current opposition by the House to budget increases, the FDA will be hard pressed to justify increased funding and it is possible that many of the provisions of the Food Safety Modernization Act will not be realized in the foreseeable future.

Reportable Food Registry alerts the FDA of safety problems that could result in serious health consequences to humans or animals

The Center for Food Safety and Applied Nutrition of the FDA has posted the first annual Reportable Food Registry document covering period September 8, 2009, through September 2010. The objective of the RFR is to alert the FDA of any safety problems that could result in serious health consequences to either humans or animals.
In terms of RFR requirements, manufacturers, processors, packers, and holders of food products regulated by the FDA are required to enter specified deviations from safety.
During the first year of operation, 229 primary reports were posted concerning food and animal feed. There were 1,872 subsequent reports from suppliers or recipients supplementing primary reports and 139 amendeds posted. Of the reports, salmonella contamination accounted for 37.6% of hazards, allergens 34.9%, and Listeria, 14% of the entries.
The primary reports included 25 commodity categories from both domestic and international sources. Salmonella was most frequently associated with rural agricultural products including spices, animal feed, nuts and seed products. The RFR will be instrumental in expediting identification of potential injurious foods and feed and will contribute to protection of food-borne outbreaks.
In commenting on the first report, Deputy Commissioner for foods Michael Taylor stated, “Several key U.S. industries are already re-evaluating their hazards and protective controls, core principles of the Food Safety Modernization Act recently passed by Congress.”